Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection
- Date
- Sep 17, 2026
- Company
- Otsuka ICU Medical LLC
- Brand
- ICU Medical LLC
- Product
- 0.9% Sodium Chloride Injection, USP, 100 mL
- Reason
- Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
- Hazard
- Other
- Source
- FDA
How to identify the product
- September 17, 2026 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up.
- The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj. 10 mEq, (NDC 0990-7074-26) Lot 1035181.
- Affected Product: The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026.
- Otsuka ICU Medical LLC is notifying its customers, including distributors, of this recall by letter and is requesting the return of all recalled products.
- Upon receipt of the completed response form, ICU Medical Customer Service will contact customers to coordinate a return label and instructions for product return.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.